Distribution valve for nasal spray

ABSTRACT

A distribution valve for nasal spray allowing to distribute a drug inside the nasal cavities in a uniform and repeatable way is described. The distribution valve has a section of elliptical or oval shape, corresponding to the shape of the nostril and it has a distribution nozzle having elliptical or oval shape (or slot shape) in order to obtain a more uniform distribution of the medicament on the inner mucosa of the nasal cavity.

This application is filed pursuant to 35 U.S.C. §371 as a United StatesNational Phase Application of Ser. No. PCT/EP01/07258 filed Jun. 26,2001, which claims priority from MI2000A001433 filed Jun. 26, 2000 inItaly.

FIELD OF THE INVENTION

The invention consists in a distribution valve for nasal spray having asection of elliptical or oval shape and showing a distribution nozzlehaving elliptical or oval shape or slot shape.

PRIOR ART

Applying inside the nasal cavities drugs in “spray” form either forpreventive purpose (for example, in order to prevent and/or mitigateallergic syndromes and/or their manifestations) or for curative purpose,for example to treat diseases of the nasal cavities (rhinitises,sinusitises, and so on) and/or to make the patient take by the nasalmucosas drugs assigned to carry out their action in other body regionsis a well known and widely consolidated practice.

The drugs normally taken in “nasal spray” form and the pursued (or whichmay be pursued) aims by the intake of such drugs will not be furtherdiscussed here because known by themselves and however extraneous to thepresent invention; such drugs, normally contained in an aerosol bomb orother airtight container, are vehiculated by a fluid (gas, air, and soon) and they are applied to the nasal mucosa by a distribution valvefixed to the drug container.

In the present description, with “distribution valve” we mean globallythe means, carried by the container, enabling to apply “in loco” thedrug and the means (not further described because known by themselves)allowing to control and to dose the delivery of the drug.

In the distribution valves of known kind the means to apply “in loco”the drug normally include a cylindrical or truncated conical body, to beinserted into a nostril, at the end of which there is a round, verysmall sized, distribution nozzle normally located at the longitudinalsymmetry axis of the above mentioned body: the drug is expelled underpressure (in a known by itself manner) through the distribution nozzleand the jet coming out from the distribution nozzle is directed varyingthe inclination angle of the longitudinal symmetry axis of thecylindrical or truncated conical body inside the nasal cavity.

Numerous studies and experimental checks showed that a drug is moreeffective if it is distributed into the nasal cavity in an extended,uniform and repeatable way, that is uniformly distributed on a wide zoneof the nasal mucosa that is, however possible, the same on eachapplication.

The distribution valves of known kind turned out not to be particularlysuitable to satisfy such need, because:

the substantially axial direction of the jet having conical shape comingout from the distribution nozzle allows to spray a limited portion ofthe nasal mucosa, as shown in FIG. 6; in order to spray the whole nasalmucosa one has to spray the drug two or three times, varying theinclination angle of the longitudinal symmetry axis of the cylindricalor truncated conical body within the nasal cavity;

the substantially cylindrical or truncated conical shape of the bodycarrying the distribution nozzle fits poorly the substantiallyelliptical or oval section of a nostril (into which it may be insertedfrom time to time with different angle) and it does not allow thereforeto direct, on each application, the jet supplied by the nozzle to thesame portion of the nasal mucosa; moreover the need to obtain a uniformdistribution of the drug on the whole mucosa of the nasal cavity varyingthe inclination angle of the longitudinal symmetry axis of the abovementioned body inside the nasal cavity involves (or may involve) therisk to damage the mucosa of the nasal septum or the nasal turbinatesone, causing bleedings and/or other injuries.

The distribution valve for nasal spray object of the present inventionallows to obtain a wider, more uniform and more repeatable, distributionof the medicament inside the nasal cavities proving to be free from theabove mentioned drawbacks presented by the distribution valves of knownkind.

SUMMARY OF THE INVENTION

The object of the present invention is a distribution valve for nasalspray including a body, to be inserted into a nostril, having a sectionof elliptical or oval shape (preferably having size equivalent to thenostril one); at the end of the above mentioned body of elliptical oroval section there is a distribution nozzle having elongated (ellipticalor oval or slot shaped) form.

By elliptical or oval section we mean a section having a major symmetryaxis and a minor symmetry axis, wherein the major axis has a lengthdifferent from the minor axis one.

BRIEF DESCRIPTION OF THE FIGURES

The invention will be better described referring to embodiment examplesnot having limitative character illustrated in the appended Figures,wherein:

FIG. 1 schematically shows a perspective view of the end of a truncatedconical distribution valve of known kind;

FIG. 2 schematically shows a perspective view of the end of adistribution valve having elliptical or oval section realized accordingto the invention;

FIG. 3 schematically shows a perspective view of the end of a variationof the distribution valve of FIG. 2;

FIG. 4 schematically shows a top view of the end of the distributionvalve of FIG. 2;

FIG. 5 schematically shows a top view of the end of the distributionvalve of FIG. 3;

FIG. 6 schematically shows an anatomical section showing the jet comingout from a distribution nozzle of known kind and its propagation insidethe nasal cavity;

FIG. 7 shows a side (FIG. 7a) view and a top (FIG. 7b) view of adistribution valve realized according to the invention, differing fromthe FIG. 2 one in that its top end is rounded;

FIG. 8 schematically shows a side view of a distribution valve realizedaccording to the invention, differing from the FIG. 3 one in that itstop end is rounded;

FIG. 9 schematically shows a side (FIG. 9a) view and a top (FIG. 9b)view of another distribution valve realized according to the invention;

FIG. 10 schematically shows an anatomical section showing the jet comingout from the distribution nozzle of the FIG. 9;

FIG. 11 schematically shows a perspective view of the end of a furtherdistribution valve realized according to the invention, analogous to theFIG. 2 one;

FIG. 12 schematically shows a top view of the end of the distributionvalve of FIG. 11;

FIG. 13 shows a transverse anatomical section of the nasal cavities;

FIG. 14 shows a distal section of the external nostrils and thevestibulum nasi. In the attached Figures, the corresponding elementswill be identified by the same numerical references.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 schematically shows a perspective view of the end of adistribution valve of known kind; in FIG. 1 the body 1 (havingsubstantially cylindrical or truncated conical shape) carrying the rounddistribution nozzle 2 and the substantially conical shaped jet 3, comingout from the distribution nozzle 2 in a substantially axial direction,allowing to spray a limited portion of the nasal mucosa, in particularin the zone of the nasal cavity which is immediately adjacent to the endof the body 1 where the distribution nozzle 2 is located, as clearlyvisible in FIG. 6, are shown.

FIGS. 2 and 3 schematically show a perspective view of the end of adistribution valve according to the invention, including the body 4whose section (taken along a plane orthogonal to the longitudinalsymmetry axis of the body 4) has elliptical or oval shape: at the end ofthe body 4 there is the distribution nozzle 5 having elongated shape,which may have elliptical or oval shape (FIG. 2; better visible in thetop view of FIG. 4) or slot shaped (FIG. 3; better visible in the topview of FIG. 5).

Obviously the elliptical or oval shapes forming the section of the body4, respectively the shape of the distribution nozzle 5 (FIGS. 2 and 4),have a major symmetry axis and a minor symmetry axis, wherein the majoraxis has a length different from the minor axis one.

The elliptical or oval section of the body 4 and the (elliptical orslot) shape of the distribution nozzle 5 allow to overcome the abovedescribed drawbacks with reference to the distribution valves of knownkind because:

the section having elliptical or oval shape of the body 4 fits thesubstantially elliptical or oval section of the nostril, wherein thebody 4 may be inserted into only with a constant angulation: on eachapplication the jet supplied by the nozzle 5 is therefore directed tothe same portion of the nasal mucosa (repeatable application of thedrug);

owing to the shape of the distribution nozzle 5 the jet 6, coming outfrom the nozzle 5 shows in turn a section which (as visible in FIG. 10)makes it suitable to spray in a more uniform way a wider portion of themucosa of the nasal cavity.

Preferably but not necessarily,

the size of the section having elliptical or oval shape of the body 4 isequivalent to a nostril one: the major axis of the external nostril andthe vestibulum nasi vary based on the different anatomical typologiesand in relation to the race and the age, so that the major axis rangesfrom 5 to 25 mm and the minor axis ranges from 3 to 15 mm;

the major axis of the distribution nozzle 5 having elliptical or ovalshape (FIGS. 2 and 4) is about 0.92 mm (and however between about 0.77and 1.17 mm), while the minor axis is about 0.4 mm and however rangingfrom about 0.3 to 0.4 mm;

the greater side of the distribution nozzle 5 having slot shape (FIGS. 3and 5) is about 0.92 mm (and however ranging from about 0.77 to 1.17mm), while the minor axis is about 0.4 mm and however ranging from about0.3 to 0.4 mm.

In the here described embodiment examples, on the external surface ofthe body 4 having elliptical or oval section there is at least alongitudinal cavity 9 (two in the FIGS. 2-5, 7-9, 11 and 12) suitable toallow the emission of the spray (in case) supplied in excess withrespect to the one absorbed (or absorbable) by the nasal mucosa and/orthe fluid which vehiculated the drug itself and to let out the pressure(in case) generated inside the nostril following the spray application,thus avoiding the risk that an overpressure (at least potentially) suchto damage the mucosa of the nasal septum and/or the nasal turbinates orthe middle ear by the Eustachian tube may generate inside the nasalcavity.

This turns out particularly advantageous if the nasal cavity or therhinopharyngeal one is (at least partially) obstructed by mucus (or byother organic fluid, caused for example by an inflammation of themucosa) preventing the excess drug and/or the fluid to naturally flowdown by rhinopharyngeal way.

Preferably but not necessarily the at least one longitudinal cavity 9has semicircular section but, without leaving the field of theinvention, it is possible to provide longitudinal cavities 9 having fromtime to time the preferred and/or the believed more functional sectionin consideration of a specific utilization.

Always without leaving the field of the invention it is possible not toinsert the at least one longitudinal cavity 9.

FIG. 6 schematically shows an anatomical section showing the jet 3coming out from a distribution nozzle 1 of known kind as, for example,the one illustrated in FIG. 1 and its propagation into the nasal cavity:from such a Figure one may point out that the jet 3 comes out from thenozzle 2 in a substantially axial direction spraying a limited portionof the mucosa not including (nor it may include) the zone of the nasalmucosa covering the higher part (or “roof”) and the lower one (or“floor”) of the nasal cavity.

FIG. 6a schematically shows a cross section of the substantiallycircular jet 3 coming out from a distribution nozzle 1 of known kind.

In order to spray in a uniform way the whole nasal cavity it isnecessary to spray the product upwards, then to the middle part of thenasal cavity and finally downwards, varying the inclination angle of thelongitudinal symmetry axis of the body 1 inside the nasal cavity.

FIG. 7 schematically shows a side view (FIG. 7a) and a top view (FIG.7b) of an embodiment form of a distribution valve having elliptical oroval shape, differing from the FIG. 2 one essentially in that the topend of the body 4, where the distribution nozzle 5 having elliptical oroval shape is realized, is rounded (or “bell-shaped”) in order tofurther reduce the risk to damage and/or irritate the nasal mucosa.

The rounded end of the body 4 where the distribution nozzle 5 isrealized has (preferably but not necessarily) semi-elliptical orsemi-oval section.

The FIGS. 7-10 moreover show the body 10, projecting with respect to thebody 4 of the distribution valve, allowing the patient to more easilyoperate the distribution valve in order to deliver the drug in “nasalspray” form.

FIG. 8 schematically shows a side view of an embodiment form of adistribution valve having elliptical or oval section, differing from theFIG. 3 one essentially in that the top end of the body 4, where thedistribution nozzle 8 having slot shape is realized, is rounded (or“bell-shaped”) in order to further reduce the risk to damage and/orirritate the nasal mucosa.

The top view of the distribution valve of FIG. 8 has been omittedbecause substantially analogous to that one illustrated in FIG. 7a.

FIG. 9 schematically shows a side view (FIG. 9a) and a top view (FIG.9b) of another form of embodiment of a distribution valve havingelliptical or oval section, differing from those ones of FIGS. 7 and 8in that it includes a further body 11 having elliptical or oval section,applied outside the body 4 of the distribution valve, whose highersurface 11 a (directed towards the end of the body 4 where thedistribution nozzle 5 is present) is tilted with respect to thelongitudinal symmetry axis of the body 4 of a first preset angle (α) todrive and position in a more precise way the body 4 and, consequently,the jet 6.

Preferably but not necessarily the body 11 moreover shows a furthertilted surface 11 b, located at an end of the higher surface 11 a, withrespect to which it is tilted of a second preset angle (β): when thedistribution valve is set to work, the tilted surface 11 b of the body11 leans on the higher lip of the patient, as better visible in FIG. 10,increasing, if necessary, the nasolabial angle which normally is about100 degrees.

Preferably the first preset angle (α) is about 70 degrees and howeverranging from about 60 to 80 degrees, while the second preset angle (β)is about 120 degrees and however ranging from about 110 to 130 degrees.

FIG. 10 schematically illustrates an anatomical section showing the jet6 coming out from the distribution nozzle of FIG. 9; from such Figureone may point out that:

the tilted surface 11 a of the body 11 leans against the edge of theexternal nostril, while the tilted surface 11 b leans on the higher lipof the patient, driving and positioning in a precise and repeatable waythe body 4;

the jet 6 coming out from the nozzle 5 has a slot shape (FIG. 10a)allowing it to deeply penetrate into the nasal cavities, which have aslot shape (FIG. 13).

FIG. 11 schematically shows a perspective view of the end of a furtherform of embodiment of a distribution valve having elliptical or ovalsection, differing from the FIG. 2 one essentially in that it alsoincludes the body 11.

FIG. 12 schematically shows a top view of the end of the distributionvalve of FIG. 11.

FIG. 13 shows an anatomical section transverse view of the nasalcavities, wherein the nasal septum 12 and the nasal turbinates 13 arepointed out; the FIG. 14 shows a distal section of the external nostrilsand the vestibula nasi.

Without leaving the field of the invention it is possible for oneskilled in the art to make to the distribution valve for nasal sprayobject of the present description all the changes and the improvementssuggested by the normal experience and by the natural evolution of theart.

What is claimed:
 1. Distribution valve for nasal spray including a body (4), to be inserted into a nostril, having a distribution nozzle (5, 8) for said spray, said valve having a cross section of elliptical or oval shape equivalent to a nostril's cross section and said nozzle having an elliptical or oval or slot shape, the surface of the body (4) having at least a longitudinal cavity (9) of a semicircular section, the end of the body (4) where the distribution nozzle (5, 8) is provided being optionally rounded, characterized in that the valve includes a further body (11) having elliptical or oval cross section, applied outside the body (4), the surface (11 a) of the further body being nearest the nozzle is tilted in a first preset angle (α) with respect to a longitudinal symmetry axis of the body (4).
 2. Distribution valve as claimed in claim 1, characterized in that the first preset angle (α) is between about 60 and 80 degrees.
 3. Distribution valve as claimed in claim 1, characterized in that the first preset angle (α) is about 70 degrees.
 4. Distribution valve as claimed in claim 1, characterized in that the further body (11) shows a further tilted surface (11 b), tilted of a second preset angle (β) with respect to the surface (11 a), suitable to lean on the higher lip of the patient when the distribution valve is set to work.
 5. Distribution valve as claimed in claim 4, characterized in that the second preset angle (β) is between about 110 and 130 degrees.
 6. Distribution valve as claimed in claim 4, characterized in that the second preset angle (β) is about 120 degrees. 